Delibera del Direttore Generale n. 277 del 12-05-2023

AZIENDA OSPEDALIERO UNIVERSITARIA XXXXX

Delibera del Direttore Generale n. 277 del 12-05-2023

Proposta n. 480 del 2023

Oggetto: ACCORDO DI RISERVATEZZA RECICPROCA DA SOTTOSCRIVERE CON HACKENSACK MERIDIAN HEALTH, INC. PRELIMINARE A POSSIBILE FUTURO STUDIO CLINICO – APPROVAZIONE SCHEMA DI ACCORDO

Dirigente: XXXXXXXX XXXXXXXX

Struttura Dirigente: RESP. MEYER CHILDREN'S RESEARCH INSTITUTE

Delibera del Direttore Generale n. 277 firmata digitalmente il 12-05-2023

AZIENDA OSPEDALIERA UNIVERSITARIA XXXXX I.R.C.C.S.

Istituto di Ricovero e Cura a Carattere Scientifico Xxxxx Xxxxxxxxxx, 00 - 00000 XXXXXXX

C.F. P.Iva 02175680483

DELIBERAZIONE DEL DIRETTORE GENERALE

Oggetto	Studio clinico
Contenuto	ACCORDO DI RISERVATEZZA RECICPROCA DA SOTTOSCRIVERE CON HACKENSACK MERIDIAN HEALTH, INC. PRELIMINARE A POSSIBILE FUTURO STUDIO CLINICO – APPROVAZIONE SCHEMA DI ACCORDO

Area Tecnico Xxx.xx	AREA TECNICO AMMINISTRATIVA
Coord. Area Tecnico Xxx.xx	XXXX XXXXX
Struttura	MEYER CHILDREN’S RESEARCH INSTITUTE
Direttore della Xxxxxxxxx	XXXXXXXX XXXXXXXX
Responsabile del procedimento	XXXXXXX XXXXXXXX
Immediatamente Esecutiva	SI

Spesa prevista	Conto Economico	Codice Conto	Anno Bilancio

Estremi relativi ai principali documenti contenuti nel fascicolo
Allegato	N° di pag.	Oggetto
1	10	Mutual Confidentiality and Non-Disclosure Agreement (Accordo di riservatezza reciproca)

“documento firmato digitalmente”

IL DIRETTORE GENERALE

Visto il D. Lgs.vo n. 502 del 30.12.1992 recante “Riordino della disciplina in materia sanitaria” e s.m.i. e la

L. R. Toscana n. 40 del 24.02.2005 e s.m.i. di “Disciplina del Servizio Sanitario Regionale”;

Richiamata la L. R. Toscana n. 12 del 16.03.2023 “Disposizioni in materia di istituti di ricovero e cura a carattere scientifico pubblici. Modifiche alla l.r. 40/2005” con la quale si è proceduto alla disciplina degli istituti di ricovero e cura a carattere scientifico di diritto pubblico ed in particolare l’art. 13 con il quale sono state dettate le “Disposizioni transitorie per il passaggio da Azienda Ospedaliero Universitaria Xxxxx ad Azienda Ospedaliera Universitaria Xxxxx IRCCS…”;

Dato atto che:

- con deliberazione del Direttore Generale n. 54 del 01.02.2021 è stato approvato il nuovo Atto Aziendale dell’A.O.U. Xxxxx, ai sensi dell’art. 6 del Protocollo d’intesa del 22.04.2002 fra Regione Toscana e Università degli Studi di Firenze, Siena e Pisa, con decorrenza dal 01.02.2021;

- con deliberazione del Direttore Generale n. 55 del 01.02.2021 sono stati assunti i primi provvedimenti attuativi in relazione alla conferma/riassetto delle strutture complesse e semplici dotate di autonomia ed al conferimento dei relativi incarichi di direzione;

- con deliberazione del Direttore Generale n. 56 del 01.02.2021 sono state assunte determinazioni attuative del nuovo Atto aziendale in relazione alla conferma/riassetto delle strutture Dipartimentali e/o a valenza dipartimentale, delle Aree Funzionali Omogenee, dell’Area Servizi dell’Ospedale, dell’Area dei Diritti del Bambino, dell’Area Tecnico Amministrativa ed al conferimento di relativi incarichi di direzione;

- con successiva deliberazione del Direttore Generale n. 92 del 15.02.2021 si è provveduto ad assumere ulteriori disposizioni attuative relative all’organizzazione dell’A.O.U. Xxxxx in ordine alle Strutture semplici Intrasoc, Unità Professionali, Uffici e Incarichi professionali;

- con deliberazione del Direttore Generale n. 443 del 23.09.2022 l'A.O.U. Xxxxx ha disposto la presa d'atto del Decreto del Ministero della Salute del 02.08.2022, pubblicato nella Gazzetta Ufficiale n. 200 del 27.08.2022, con cui l’Azienda Ospedaliero Universitaria Xxxxx è stata riconosciuta Istituto di Ricovero e Cura a Carattere Scientifico (I.R.C.C.S.), per la disciplina di pediatria;

Richiamata la deliberazione n. 206 del 05.04.2023 con la quale si prende atto dell’attribuzione al Direttore Amministrativo, Dr. Xxxx Xxxxx, delle funzioni di Direttore Generale, ai sensi dell’art. 3, comma 6 del D. Lgs.vo n. 502/1992 e dell’art. 14 dell’Atto Aziendale;

Su proposta del Direttore Operativo del Meyer Children’s Research Institute, Dr.ssa Xxxxxxxx XxXxxxxx, la quale, con riferimento alla presente procedura, ne attesta la regolarità amministrativa e la legittimità dell’atto;

Ricordato che questa Azienda, tra le proprie finalità istituzionali, promuove la ricerca scientifica con lo scopo di raggiungere risultati di eccellenza nella cura in campo pediatrico e che taluni progetti di ricerca, prima del loro avvio, necessitano di una fase preliminare atta ad esplorarne la fattibilità presso le proprie strutture;

Considerato che Hackensack Meridian Health, Inc., un’organizzazione sanitaria senza scopo di lucro con sede negli Stati Uniti, ha manifestato il proprio interesse in un settore della ricerca pediatrica che

coinvolge il Xxxx. Xxxxxxxx Xxxxxxxx e che è nelle intenzioni di questa Azienda esplorare la possibilità di condurre uno studio clinico internazionale nel campo della reumatologia pediatrica;

Xxxxxxxxx che è, altresì, nell’interesse di questa Azienda garantire la valorizzazione della ricerca in pediatria e, pertanto, scambiare con la suddetta organizzazione e gli altri partner coinvolti nel progetto di ricerca, attraverso apposito Accordo di riservatezza reciproca, talune informazioni riservate necessarie per esaminare l’opportunità e la realizzabilità di uno studio clinico;

Verificato che dall’Accordo di cui sopra non derivano oneri economici a carico dell’AOU Xxxxx IRCCS;

Ritenuto pertanto di stipulare l’Accordo reciproco di riservatezza con Hackensack Meridian Health, Inc. e gli altri partner internazionali per la disciplina delle condizioni normative ed operative per la tutela delle informazioni confidenziali scambiate tra le parti dell’Accordo, nella versione integrale conservata agli atti;

Rilevata l’opportunità di dichiarare il presente atto immediatamente eseguibile per consentire che le informazioni confidenziali siano oggetto di reciproco scambio in tempi congrui con le esigenze di confronto tra le parti dell’Accordo, nel breve periodo, sullo studio clinico;

Considerato che il Responsabile del Procedimento, individuato ai sensi della Legge n. 241/1990 nella persona del Dr. Xxxxxxx Xxxxxxxx, sottoscrivendo l’atto attesta che lo stesso, a seguito dell’istruttoria effettuata, nella forma e nella sostanza è legittimo;

Acquisito il parere del Dr.ssa Xxxxx Xxxx, Coordinatore dell’Area Tecnico Amministrativa, espresso mediante sottoscrizione del presente atto;

Vista la sottoscrizione del Direttore Sanitario e del Direttore Amministrativo, per quanto di competenza, ai sensi dell’art. 3 del Decreto Legislativo n. 229/99;

DELIBERA

Per quanto esposto in narrativa che espressamente si richiama,

1) Di approvare lo schema di Accordo di riservatezza reciproca da stipulare con Hackensack Meridian Health, Inc., e le altre parti dell’Accordo che, allegato N. 1 al presente atto, ne forma parte integrante e sostanziale.

2) Di dare atto che dall’Accordo di cui sopra non derivano oneri economici a carico dell’AOU Xxxxx IRCCS.

3) Di dichiarare il presente atto immediatamente eseguibile ai sensi dell’art. 42, comma 4 della

L.R. T. n. 40/2005 in considerazione della necessità di procedere in tempi brevi alla sottoscrizione del su citato Accordo e consentire così nell’immediato la discussione reciproca tra le parti su uno studio clinico internazionale.

4) Di trasmettere il presente atto al Collegio Sindacale ai sensi dell’art. 42, comma 2, della L.R.T. n. 40/2005 contemporaneamente all’inoltro all’albo di pubblicità degli atti di questa A.O.U. Xxxxx I.R.C.C.S.

IL DIRETTORE GENERALE f.f.
(Dr. Xxxx Xxxxx)
IL DIRETTORE SANITARIO	IL DIRETTORE AMMINISTRATIVO
(Dr.ssa Xxxxxxxxx Xxxxxxx)	(Dr. Xxxx Xxxxx)

MUTUAL CONFIDENTIALITY AND NON-DISCLOSURE AGREEMENT (THE “AGREEMENT”)

THIS CONFIDENTIALITY AGREEMENT (the “Agreement”) is made by and between XXXXXXXXXX MERIDIAN HEALTH, Inc., a New Jersey non-profit corporation having a place of business at 000 Xxxxxxxx Xxxxxx, Xxxxxx, XX 00000 (“HMH” or “INSTITUTION”), and any other party that is a signatory hereto and acknowledged by INSTITUTION as a participant (“Participant”) to research being funded by the National Scleroderma Foundation (“Research”). This Agreement shall govern the conditions of disclosure by any party of proprietary and/or confidential information as defined below of the parties for the consideration of a possible relationship among the parties or among their investigators for the performance of research within RESEARCH.

Each of HMH and Participant are individually referred to herein as a “Party” and collectively referred to herein as the “Parties.” A Party includes the respective companies and their subsidiaries, successors, assigns, legal representatives, affiliates, employees, agents, servants, advisors, attorneys, accountants, and consultants (hereinafter sometimes referred to as the “Representatives”), but only to the extent each discloses or receives Confidential Information hereunder, all of whom agree to be bound by the terms and conditions of this Agreement. “Affiliate” shall mean any corporation or other business entity that directly or indirectly controls, is controlled by, or is under common control with a party; “control” means ownership or other beneficial interest in 50% or more of the voting stock or other voting interest of a corporation or other business entity.

The Parties are willing and agree to disclose to each other certain of their confidential, non- public information concerning their respective proprietary products, technology, research, programs, business plans, financials, facilities, business records data, personal data, test results and any other proprietary, non-public information prepared by or for each of them (collectively, the “Confidential Information”) for the purpose as defined below. All material that is written, in hard media, digital or other format shall automatically be considered as Confidential Information. If the information is disclosed orally or visually, then it shall be deemed to be Confidential Information if the disclosure is reduced to writing, marked “CONFIDENTIAL” and delivered to the Recipient within thirty (30) days of the date of disclosure. A Party disclosing Confidential Information shall be referred to as the “Discloser” and a Party receiving Confidential Information shall be referred to as the “Recipient”.

The purpose of this Agreement is for the Parties to consider a possible research relationship for the performance of research among the Parties as it may relate to the “Developing Classification Criteria for Juvenile Systemic Sclerosis: An International Effort to Enable Pediatric- focused Clinical Trials” (the “Purpose”). Each Party understands that the other Party has disclosed or intends to disclose Confidential Information to the other for the Purpose. Nothing in this Agreement shall be construed, by implication or otherwise, as a grant by one Party to the other Party of any right or license to trademarks, inventions, copyrights or patents, as a grant of a license to a Recipient to use any of the Discloser’s Confidential Information except as expressly set forth herein, or as an obligation to enter into any further agreements relating to any Confidential Information or any possible business relationship. All Confidential Information, shall remain the property of the Discloser, and no license or other rights to such Discloser’s Confidential

Information is granted or implied hereby. In the event the parties enter into a future agreement addressing the Purpose, the terms of that future agreement shall supersede this Agreement. Accordingly, except necessary for the Purpose, the Recipient agrees that it will not use Confidential Information received from or on behalf of the Discloser for the purpose of discovering an invention whether patentable or not; patenting material or any improvement thereon; copyrighting material; or securing any trade secrets or other intellectual property rights. In that context, Recipient understands and agrees that it will not, for itself or in conjunction with others, directly or indirectly, test, modify, manipulate, research, create a derivative including, but not limited to, performing activities to understand structure activity relationships, mechanism activity relationships or mechanism of action of particular compounds, reverse engineer, replicate the Confidential Information, or otherwise work with or manipulate the Confidential Information in an effort to understand the Discloser’s proprietary technology or learn information not explicitly stated in the Confidential Information. Such testing, manipulation, replication, work, reverse engineering or other research may only be undertaken and conducted through negotiated transactional documents which are mutually accepted, executed and delivered by the applicable Parties. This Agreement is not a transactional document. The Recipient shall be liable for any and all direct and indirect damages, costs and expenses resulting from any violation of the above paragraph including, without limitation, reasonable attorneys’ fees and disbursements, consequential damages and lost profits. In consideration of the willingness of the Parties to disclose their respective Confidential Information to each other and, in recognition of the confidential nature thereof, the Parties hereby each agree that the Confidential Information received from or on behalf of the other, will, during the term of this Agreement and for a further period of five (5) years following the expiration or termination of this Agreement, be kept strictly confidential and will be used solely for the Purpose; and will not be disclosed, distributed or disseminated to any person, firm or entity other than a Representative without the prior written consent of the Discloser. The Parties each agree that they will be responsible for any violation of this Agreement by a Representative, and that their respective Representatives shall keep such Confidential Information confidential. Prior to disclosing Confidential Information to a Representative, the Discloser shall inform the Representative that: (i) the information constitutes Confidential Information, (ii) the Confidential Information is being provided in accordance with the terms and conditions of this Agreement and (iii) the Representative is, by accepting the Confidential Information bound by and subject to the terms and conditions of the Agreement.

Further, the Parties agree to comply with all Applicable Laws in relation to the protection of Confidential Information and agree to take such steps to protect and maintain the security and confidentiality of the Confidential Information as each Party would take in the case of their own confidential information but in no event less than a reasonable degree of care. Such reasonable degree of care shall include maintaining appropriate technical and organizational security measures to protect the confidentiality and security of Confidential Information adapted to the nature and sensitivity of the information to be protected and that such security program conforms to applicable privacy and security laws, including but not limited to HIPAA and including appropriate physical, electronic, an procedural safeguards to (1) ensure the security and confidentiality of Confidential Information; (2) protect against any threats or hazards to the security or integrity of Confidential Information, and (3) prevent unauthorized access to or use of Confidential Information. The Parties agree that all servers, workstations, laptops and other systems that process and/or store Confidential Information must be protected by encryption that provides reasonable and adequate protection and comports with at least industry standards. The Parties agree that all electronic transmissions of Confidential Information must be similarly encrypted, including transmissions between and among Party provided software modules and other

endpoints. The Parties shall prohibit the creation of unencrypted copies of Confidential Information.

The Recipient agrees to notify the Discloser immediately within twenty-four (24) hours upon discovery of any unauthorized use or disclosure of Confidential Information or any other breach of this Agreement by the Recipient or its Representatives and will cooperate with the Discloser in every reasonable way to help the Discloser regain possession of the Confidential Information and prevent its further unauthorized use or disclosure. A Party causing such an actual or suspected breach will reimburse the affected Party(ies) for all costs, expenses and damages (including reasonable attorneys’ fees) associated with any notification process that may be required under federal or state law.

The restraint on confidentiality provided herein shall not apply to any Confidential Information which:

a) Is or subsequently becomes part of the public domain through no fault of a Recipient; or

b) Was known by the Recipient at the time of disclosure and such prior knowledge can be demonstrated by the Recipient through its competent written records contemporaneously made;

c) Is independently developed by the Recipient without use or consideration of the Confidential Information;

d) Is rightfully received by a Recipient from a third party not owing a duty of confidentiality to the Discloser; or

e) Is required by law to be disclosed, after notice to the Discloser and an opportunity for the Discloser to seek injunctive relief and/or an appropriate Protective Order.

Notwithstanding the foregoing, any combination of features or disclosures shall not be deemed to fall within the foregoing exclusions merely because individual features are published or available to the public or in the rightful possession of the Recipient unless the combination itself and principle of operation are published or available to the general public or are in the rightful possession of the Recipient.

All Confidential Information is being delivered “AS IS” without any representations or warranties of any nature or kind and none are intended or implied. No Party shall be liable to the other in any manner whatsoever for any decisions, obligations, costs or expenses incurred, changes in business practices, plans, organization, products, services, or otherwise, based on either Party’s decision to use or rely on any information exchanged under this Agreement.

The Parties do not intend that any agency, partnership, joint venture, or exclusive relationship is created between the Parties by this Agreement and each Party is free to pursue relationships and opportunities with others that are like those contemplated by this Agreement.

It is agreed and understood that all documents and other materials which embody the Confidential Information will be returned to the Discloser immediately upon request, and no copies, extracts or other reproductions shall be retained by the Recipient or the Representatives

except that one (1) archival copy may be retained by the Recipient in a secure environment solely to enable the Recipient to determine the scope of its continuing obligation of confidentiality under this Agreement.

The Parties each agree that money damages may not be a sufficient remedy for any breach of this Agreement by the other or their Representatives, and the Parties, as the case may be, shall be entitled, in addition to money damages, to seek specific performance and injunctive relief and any other appropriate equitable remedies for any such breach. Such remedies shall not be deemed to be the exclusive remedies for a breach of this Agreement but shall be in addition to all other remedies available at law or in equity.

This Agreement shall be governed by, and construed in accordance with, the internal laws of the State of New Jersey without giving effect to any choice or conflict of laws provision or rule that would cause the application of laws of any jurisdiction other than those of the State of New Jersey. All disputes shall be resolved in Bergen County, New Jersey. The Parties represent and warrant to each other that the individual signing on their respective behalf has been duly authorized and empowered to execute and deliver this Agreement and the Agreement, when fully signed and delivered, is binding on the Party.

Nothing in this Agreement shall provide either Party the right to use the name or likeness of the other Party for any reason without the prior written consent of an authorize signatory of the requested Party.

This Agreement and all rights and obligations hereunder shall not be assigned (whether through merger or consolidation, by operation of law, or otherwise) without the written consent of the other Parties, and any attempt to assign without such consent shall be void provided, however, that a Party shall be permitted to assign this Agreement without consent to an Affiliate or any successor in interest to all or substantially all of the assets to which this Agreement relates and provide written notice to the other Parties of any such assignment.

The Parties agree to adhere to all applicable laws, regulations and rules including those relating to the export of technical data, and shall not export or re-export any technical data, any samples or prototypes received hereunder, or the direct product of such technical data to any country prohibited by such applicable laws, regulations and rules unless properly authorized.

Each of the Parties acknowledge that one or more Parties may sign this Agreement as an additional CRO subsequent to the initial execution of this Agreement. The Parties may disclose and receive Confidential Information from any such additional CRO in accordance the terms herein upon receipt from a Party a copy of such additional CRO’s signature to this Agreement.

Any waver of compliance with the terms of this Agreement must be in writing, and any waiver in one instance shall not be deemed a wavier in any future instance.

This Agreement supersedes all prior agreements for the Purpose as previously identified herein.

The Parties agree that this Agreement may be executed and delivered by facsimile, electronic mail, internet, or any other suitable electronic means, and the Parties agree that

signatures delivered by any of the aforementioned means shall be deemed to be original valid, and binding upon the Parties.

In the event the terms of this Agreement need to be interpreted into a language asides from English, those Parties utilizing an interpreted Agreement attest that they have had this Agreement interpreted and they now understand and agree to the terms and conditions of this Agreement.

This Agreement and its terms and conditions are hereby acknowledged, accepted and agreed to:

HMH-Xxxxxx X Xxxxxxx Children’s Boston Children’s Hospital Hospital

By: By: Name: Xxxxxx Xxxxxxx Name:

Title: Title:

Date: Date:

The Hospital for Sick Children, Children’s Hospital of Pittsburgh,

University of Toronto University of Pittsburgh

By: By:

Medicine

By: By:

Rheumatology and Rehabilitation Foundation Trust

By: By:

Medical School of Medicine, National Clinical Niigata University Graduate School of Research Center For Child Health, Zhejiang Medical and Dental Science

By: By:

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